STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders

Synta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: AML; CML; MDS; Myeloproliferative Disorders

Treatments: Drug: STA-9090 (ganetespib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858572

9090-03

Details and patient eligibility

About

The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Males and females 18 years or older
• Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol
• Must have acceptable organ function during screening as defined in the protocol

Exclusion Criteria

• Pregnant or breast-feeding women
• Patients must meet the washout periods for prior chemotherapies and radiation
• History of stroke within 6 months of treatment
• Poor venous access for study drug administration
• Treatment with chronic immunosuppressants
• Other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Cohort

Experimental group

Treatment:

Drug: STA-9090 (ganetespib)